Cleared Traditional

K110001 - SPACELABS PATHFINDER SL HOLTER ANALYZER

K110001 is an FDA 510(k) clearance for SPACELABS PATHFINDER SL HOLTER ANALYZER, manufactured by Spacelabs Healthcare, Ltd.. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K110001 · Spacelabs Healthcare, Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2011
Decision
162d
Days
Class 2
Risk

K110001 is an FDA 510(k) clearance for the SPACELABS PATHFINDER SL HOLTER ANALYZER. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Spacelabs Healthcare, Ltd. (Nederland, US). The FDA issued a Cleared decision on June 14, 2011 after a review of 162 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Spacelabs Healthcare, Ltd. devices

FDA 510(k) Submission Details - K110001

510(k) Number K110001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2011
Decision Date June 14, 2011
Days to Decision 162 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 125d · This submission: 162d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQK Device Classification - Class 2, Special Controls

Product Code DQK Computer, Diagnostic, Programmable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1425
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DQK Computer, Diagnostic, Programmable

All 270
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K110001.
ENSITE VELOCITY SYSTEM V.3.0
K112688 · St Jude Medical · Nov 2011
MAC-LAB SYSTEM, CARDIOLAB SYSTEM, COMBOLAB SYSTEM, SPECIALSLAB SYSTEM
K111200 · Ge Healthcare · Oct 2011
CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.2
K112007 · Biosense Webster, Inc. · Oct 2011
MUSE CARDIOLOGY INFORMATION SYSTEM
K110132 · Ge Medical Systems Information Technologies, Inc. · May 2011
ENSITE VELOCITY SYSTEM
K110549 · St Jude Medical · May 2011
CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.0 (W/STANDARD LOCATION PAD),CARTO3 EPNAVIGATION SYSTEM,VERSION 2.0 W/RMT PAD)
K103746 · Biosense Webster, Inc. · Jan 2011